| Literature DB >> 18091762 |
C A Altar1, D Amakye, D Bounos, J Bloom, G Clack, R Dean, V Devanarayan, D Fu, S Furlong, L Hinman, C Girman, C Lathia, L Lesko, S Madani, J Mayne, J Meyer, D Raunig, P Sager, S A Williams, P Wong, K Zerba.
Abstract
A framework for developing evidentiary standards for qualification of biomarkers is a key need identified in the Food and Drug Administration's Critical Path Initiative. This article describes a systematic framework that was developed by Pharmaceutical Research and Manufacturers of America (PhRMA) committees and tested at a workshop in collaboration with the Food and Drug Administration and academia. With some necessary refinements, this could be applied to create an appropriately individualized evidentiary standard for any biomarker purpose.Mesh：
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Year: 2007 PMID： 18091762 DOI： 10.1038/sj.clpt.6100451
Source DB: PubMed Journal: Clin Pharmacol Ther ISSN： 0009-9236 Impact factor: 6.875